BEUDAMED
    FDA PMA FDA Unclassified Approved (Withdrawn) 🇺🇸 United States

    Separator, Automated, Blood Cell And Plasma, Therapeutic

    PMA: P850092 · Decision Nov 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Separator, Automated, Blood Cell And Plasma, Therapeutic
    Trade Name
    THERAPEUTIC APHERESIS SYSTEM
    PMA Number
    P850092
    Device Class
    FDA Unclassified
    Product Code
    LKN
    Generic Name
    Separator, automated, blood cell and plasma, therapeutic
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 18, 1986
    Date Received
    December 18, 1985
    Expedited Review
    N
    Docket Number
    86M-0481

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LKN Separator, Automated, Blood Cell And Plasma, Therapeutic